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CAR T-cell Therapy

AZD0754 for Prostate Cancer (APOLLO Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue

Participants with a histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

APOLLO Trial Summary

"This trial aims to test the safety and effectiveness of AZD0754 CAR T-cell therapy in people with advanced prostate cancer."

Who is the study for?

This trial is for individuals with metastatic prostate cancer. Participants should meet specific health criteria to be eligible, but the exact inclusion and exclusion details are not provided.Check my eligibility

What is being tested?

The study is testing AZD0754 CAR T-cell therapy's safety, how well people can handle it, and its effectiveness in treating metastatic prostate cancer.See study design

What are the potential side effects?

While specific side effects of AZD0754 are not listed, common side effects of CAR T-cell therapies may include flu-like symptoms, fatigue, fever, and potential neurological events.

APOLLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is growing despite hormone therapy.

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My prostate cancer has spread, and it's not small cell or neuroendocrine type.

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I have had treatments like abiraterone or taxane for prostate cancer, or I cannot or will not take taxane.

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My PSA level is at least 1 ng/mL and it has increased in the last 6 months.

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I have HRR deficiency or a BRCA mutation and have tried or can't tolerate PARP inhibitors.

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I have received at least one checkpoint inhibitor treatment for my cancer with high microsatellite instability.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

APOLLO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs).

Presence of replication-competent lentivirus (RCL) in peripheral blood samples

Secondary outcome measures

Best Overall Response (BOR)

Biomarker - STEAP2 expression in Tumor

Disease Control Rate (DCR)

+19 more

APOLLO Trial Design

1Treatment groups

Experimental Treatment

Group I: AZD0754Experimental Treatment1 Intervention

AZD0754 monotherapy for treatment of participants with metastatic prostate cancer.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,643 Total Patients Enrolled

60 Trials studying Prostate Cancer

27,522 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to take part in this clinical trial?

"Individuals with a diagnosis of prostate cancer aged between 18 and 130 are eligible for enrollment in this study, which has space for up to 60 participants."

Answered by AI

What is the total number of participants being recruited for this research study?

"Affirmative. Information available on clinicaltrials.gov confirms that this specific clinical trial is currently seeking eligible participants. Originally posted on February 19, 2024, the most recent update was also on February 19, 2024. The study aims to enroll a total of 60 patients across eight different sites."

Answered by AI

Are individuals aged 50 and above eligible to participate in this research study?

"Recruitment for this investigation targets individuals over 18 years old but below the age of 130."

Answered by AI

Is the enrollment process open for this medical study at present?

"Affirmative. Details on clinicaltrials.gov highlight the ongoing recruitment of participants for this trial, first listed on February 19th, 2024 and most recently revised on the same date. The study aims to enroll a total of 60 individuals across 8 designated sites."

Answered by AI

In how many different medical centers can patients access this clinical trial?

"At present, patient recruitment is ongoing at 8 research sites. These include New york, Tampa, and Atlanta among additional locations. Opting for the nearest site upon enrollment is crucial to reduce travel constraints."

Answered by AI

What is the primary objective of this medical study?

"The primary aim, to be evaluated throughout a projected 2-year duration of the study, is to monitor the incidence of participants experiencing Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs). Additionally, secondary outcomes will encompass measuring Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Event (SSRE), Prostate-specific antigen (PSA) response rate - PSA50 which signifies achieving a ≥ 50% reduction in PSA levels from baseline confirmed by subsequent assessments"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AZD0754 in Participants With Metastatic Prostate Cancer

2024. "Study of AZD0754 in Participants With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06267729.

All > Prostate Cancer Tampa > Metastatic Prostate Cancer